BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3092038 · Received May 3, 2013

    Report

    Report Number
    2531779-2013-05844
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP¿S BLACK BOX HISTORY SHOWED THE PUMP WAS NOT IN USE BETWEEN (B)(6) 2013 AT 07:09 AND (B)(6) 2013 AT 18:23. THE BLACK BOX SHOWED 55 UNITS REMAINING IN THE PUMP BEFORE THE 6.9 UNIT BOLUS WAS PERFORMED; AFTER THE BOLUS WAS COMPLETED, 48 UNITS REMAINED IN THE PUMP. A CARTRIDGE WITH 183 UNITS WAS LOADED INTO THE PUMP. A 10 UNIT AUDIO AND 10 UNIT NORMAL BOLUS WERE SUCCESSFULLY COMPLETED; THE PUMP CORRECTLY CALCULATED THE REMAINING UNITS WITH EACH STEP. NO HYPERSENSITIVE KEYS WERE OBSERVED ON KEYPAD. THE PUMP SUCCESSFULLY COMPLETED THE REQUIRED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATION. THE HISTORY/DELIVERY ISSUE WAS NOT DUPLICATED DURING THE INVESTIGATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING A BLOOD GLUCOSE OF 22 MMOL/L WITH ACHING IN JOINTS AND BONES. THE PATIENT REPORTED THAT THERE WERE NO ALARMS IN THE PUMP HISTORY AND CONFIRMED THAT THE BASAL AND BOLUS HISTORY ADDED UP CORRECTLY. THE PATIENT INDICATED THAT A 6.9 UNIT BOLUS WAS DELIVERED BUT THE PUMP'S INSULIN REMAINING READING ONLY CHANGED BY 1 UNIT FROM 48 UNITS REMAINING TO 47 UNITS REMAINING. THE PATIENT CONFIRMED THAT IN THE PUMP HISTORY THE BOLUS SHOWED AS BEING DELIVERED IN FULL. THE REPORTED BLOOD GLUCOSE DOES NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PUMP HISTORY/DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194173 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR